Newer Liquid Versions of Children’s Meds Greatly Exceed Costs of Older Tablets

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Over the past three years, liquid formulations of a few older medicines were approved for children, but these have come with a price — a steep price. Although youngsters must no longer struggle to swallow tablets or run the risk of compounded liquid versions, the cost of these new preparations greatly outstrips both generic tablets and the compounded alternatives, according to a letter published today in the New England Journal of Medicine.

The authors noted that the US Food and Drug Administration approvals are the result of a valiant effort — encouraging greater development of pediatric medicines. But as they see it, the facts on the ground turn out to be just another variation on an increasingly common theme: companies finding ways to revamp older medicines and thwarting competition after gaining the imprimatur of the FDA.

For instance, the Qbrelis medicine, which is used for treating pediatric hypertension in children six years of age and older, costs 775 times more than a 10-mg generic tablet. And the Epaned medicine, which is approved for treating hypertension in babies one month and older, is 21 times more costly than a 5-mg generic tablet, according to their letter. Epaned was approved by the Food and Drug Administration in 2013, while Qbrelis was approved last year.

Here is how the authors explain this predicament. The companies received patent protection for concocting liquid formulations. And once a liquid formulation is approved, pharmacies are not allowed to crush generic tablets to make a compounded liquid version. In the past, a month’s supply of a compounded version might have cost a pharmacy just $20, but the wholesale acquisition cost of the approved formulation costs $1,000 or more, they wrote.

“The availability of standardized liquid drug preparations clearly benefits children, and there are research and development costs for introducing them,” wrote Dr. Thomas Welch, the medical director at Upstate Golisano Children’s Hospital in Syracuse, N.Y., and Luke Probst, the pharmacy director there. “Intuitively, though, the costs should be less than the costs to develop an entirely new drug.”

In an e-mail to us, Welch continued: “These are not ‘new’ drugs. Indeed, many have been used for decades. It should not be difficult to establish their efficacy and safety, in that the tablet forms have been used literally millions of times. The issues with the new liquid formulations are more around things like the stability of the drug in the [liquid form] and its absorption in the body compared to tablet form. These sorts of studies are hardly comparable to [the costs] required in rolling out an entirely new drug.”

Both of the hypertension drugs were the most egregious examples cited in the letter. They are made by Silvergate Pharmaceuticals, which did not respond to a request for comment. However, the company has web sites for each of the drugs that indicate customers with commercial insurance will not pay more than $30 for a prescription, suggesting that insurers bear the bulk of the cost (see here and here).

In any event, the authors suggest “streamlining” regulatory requirements for developing pediatric drug formulations and adopting “responsible pricing models” to try to solve the problem, although they are admittedly short on specifics. Nonetheless, they lament that “there must be a better way to support the costs of developing the drug formulations that many children and some severely impaired adults desperately need.”